Product Development Engineer I

Freudenberg Medical; Minnetonka (MN); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

401K Match

Sustainability & Social Commitment

Diversity & Inclusion

Personal Development

Employee discounts

Job summary

Freudenberg Medical in Minnetonka, MN is seeking a Product Development Engineer I to assist in design and development of medical devices, prototypes, and design documentation in compliance with regulatory and quality requirements.

You will collaborate with cross-functional teams, support risk assessments, testing, and documentation, contribute to manufacturability and cost targets, and help with design for manufacturability and transition to production.

Qualifications

• Bachelor's degree in Engineering and related science.
• 0-3 years in medical device or internship/academic experience.
• Familiarity with GMP principles and regulatory requirements.
• 3D solid modeling and technical drawings experience.
• Understanding of Design for Manufacturability (DFM).
• Ability to communicate technical ideas clearly and document work.

Responsibilities

• Assist design and development of new and existing medical devices with specs, prototypes, and documentation.
• Support design reviews, risk assessments, and verification testing for safety and efficacy.
• Assist build/test of prototypes, select materials, and develop processes and test methods.
• Collaborate cross-functionally to ensure manufacturability, regulatory compliance, and cost targets.
• Prepare and maintain design/development documentation per ISO/regulatory standards.
• Participate in project execution, meetings, and testing coordination to meet timelines.
• Support product launches and transition to NPI/production, resolving issues and driving improvement.

Skills

GMP principles

DFM

3D solid modelling

Technical drawings

Prototyping basics

Communication

Education

Bachelor's degree in Engineering

Job description

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.
Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies.
With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

401K Match: Save for retirement with the company's help.
Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
Personal Development: We offer a variety of trainings to ensure you can develop in your career.
Employee discounts: Opportunities for deals on products and services.
*Candidates must be legally authorized to work in the United States without current or future visa sponsorship*
We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.
Minnetonka, MN
On-Site
Freudenberg Medical LLC
payments The expected salary range for this position is $75,000 to $90,000 USD annually, depending on skills, experience, and qualifications.
You support our team as

Product Development Engineer I

Responsibilities

• Assist in the design and development of new and existing medical devices by developing specifications, prototypes, and design documentation in compliance with regulatory and quality requirements.
• Support the preparation of design/development documentation; participate in risk assessments, design/project reviews, and verification testing to ensure product safety and efficacy.
• Assist in the build and testing of prototype devices, select appropriate materials, and assist with developing processes, test methods and characterization studies.
• Collaborate cross-functionally with NPI, manufacturing, quality, regulatory, suppliers and customers to learn and support design/process activities that ensure manufacturability, regulatory compliance, and cost-effectiveness.
• Assist in the preparation and maintenance of design/development documentation, in accordance with ISO, applicable regulatory and company standards.
• Participate in project execution by managing tasks, participating in team meetings, maintaining accurate engineering documentation, and coordinating testing activities with internal and external partners to meet project timelines and deliverables.
• Support product launches by providing engineering input during transition to NPI/ production, resolving technical issues, and contributing to continuous improvement efforts.
• Contribute to early-stage innovation efforts by researching new technologies and supporting technical feasibility assessments under the guidance of senior engineers.
• Ability to manage multiple tasks and adapt to a changing, fast-paced environment.
  

Qualifications

• Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field.
• 0-3 years of engineering in medical device or related industry experience (or Internship or academic experience).
• Familiarity with GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements.
• Working knowledge or coursework in 3D solid modeling and technical drawings
• Basic understanding of creating prototypes using various materials and techniques to test and validate product designs.
• Awareness of Design for Manufacturability (DFM) principles to design products that are manufacturable and cost effective.
• Ability to communicate technical ideas clearly, ask thoughtful questions, and document work accurately.
  

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.